A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC

Who is this study for? Patients with stage I-IIA non-small cell lung cancer
Status: Active_not_recruiting
Location: See all (391) locations...
Intervention Type: Other, Drug, Procedure, Radiation
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This phase III trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving atezolizumab and radiation therapy may work better than radiation therapy alone in treating patients with early non-small cell lung cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient must have histologically or cytologically proven stage I-IIA or limited T3N0M0 non-small cell lung cancer (NSCLC), without radiographic evidence of nodal or distant involvement (N0M0). Patient may have T3 disease with the exclusion of pericardial involvement. Patients with multifocal tumors with no more than two lesions confirmed or suspected to be synchronous early stage NSCLCs are eligible provided at least one lesion is histologically or cytologically proven to be NSCLC and meets one or more high-risk features

• Disease must have one or more of the following high-risk features:

‣ Tumor diameter \>= 2 cm (inclusive of any non-solid, ground glass component) as assessed by diagnostic CT

⁃ Tumor standard uptake value (SUV) max \>= 6.2 as assessed by FDG PET/CT

⁃ Moderately differentiated, poorly differentiated, or undifferentiated histology

• Patient must have undergone diagnostic chest CT with or without contrast (IV contrast preferred) within 42 days prior to randomization. PET-CT may be used if the CT portion is of comparable diagnostic quality to a stand-alone CT. All disease must be assessed within 42 days prior to randomization

• Patient must have undergone FDG PET/CT of chest within 90 days prior to randomization

• Patient must not have evidence of hilar or mediastinal nodal involvement. Any patient with radiographically suspicious hilar or mediastinal nodes (including features such as non-calcified nodes with a short axis diameter \> 1 cm, abnormal morphology, and/or elevated FDG avidity) must undergo cytologic sampling of suspicious nodes to rule out involvement prior to randomization. Mediastinal nodal sampling for other patients is optional. For cases in which the treating physician/multidisciplinary opinion is used to define nodes as non-suspicious (such as long-standing, stable enlarged nodes from other medical causes), the rationale must be clearly documented within the medical record

• Patient must have undergone history and physical examination within 28 days prior to randomization

• Patient must be medically or surgically inoperable as documented by the evaluating thoracic surgeon or multi-disciplinary tumor board consensus OR patient's unwillingness to undergo surgical resection must be clearly documented

• Patient must not have received any prior treatment for the current NSCLC diagnosis

• Patient must not have undergone prior radiation to overlapping regions of the chest that, in the opinion of the treatment physician, will interfere with protocol treatment

• Patient must not have received treatment with systemic immunostimulatory or immunosuppressive agents, including corticosteroids, within 14 days prior to randomization

• Patient must be \>= 18 years old

• Patient must have Zubrod performance status of 0-2

• Patient must have adequate liver function defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x institutional upper level of normal (IULN) within 28 days prior to randomization

• Patient must have adequate renal function defined as calculated creatinine clearance \>= 30 mL/min using the following formula. The serum creatinine value used in the calculation must have been collected within 28 days prior to randomization

• Patient must have absolute neutrophil count (ANC), platelets, and hemoglobin measured within 28 days prior to randomization. The purpose of these tests is to collect baseline values to compare with on-treatment values

• Patient must have thyroid-stimulating hormone (TSH) measured within 28 days prior to randomization. The purpose of this test is to collect baseline values to compare with on-treatment values

• Patient must not have significant cardiovascular disease (New York Heart Association \[NYHA\] class II or greater)

• Patient must not have myocardial infarction within 90 days prior to randomization

• Patient must not have unstable arrhythmias or unstable angina

• Patient must not have known left ventricular ejection fraction (LVEF) \< 40% within 28 days prior to randomization

‣ NOTE: Assessment of LVEF by echocardiogram or multigated acquisition (MUGA) is not an eligibility requirement, but if a standard of care echocardiogram or MUGA was clinically indicated, the LVEF must not be \< 40% within 28 days prior to randomization

• Patient must not have had an infection \>= grade 3 (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) within 28 days prior to randomization

• Patient must not have an active autoimmune disease that has required systemic treatment in past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed

• Patient must be tested for hepatitis B within 28 days prior to randomization. Patient must not have active (chronic or acute) hepatitis B virus (HBV) infection. Patients may have past or resolved HBV infection

‣ Active HBV is defined as having a positive hepatitis B surface antigen (HBsAg) test

⁃ Past or resolved HBV is defined as having a negative HBsAG test and a positive total hepatitis B core antibody (HBcAb) test

• Patient must be tested for hepatitis C within 28 days prior to randomization. Patient must not have active hepatitis C virus (HCV) infection

‣ Active HCV is defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test

• Patient must have pulmonary function testing to include, at a minimum, forced expiratory volume in 1 second (FEV1) and Diffusing capability of carbon monoxide (DLCO) documented within 90 days prior to randomization

• Patients with known human immunodeficiency virus (HIV) infection must be receiving anti-retroviral therapy and have an undetectable viral load at their most recent viral load test within 6 months prior to randomization

• Patient must not have a history of clinically significant interstitial lung disease or evidence of active pneumonitis on the screening chest CT

• Patients must not have a prior or concurrent malignancy whose natural history or treatment has the potential (in the opinion of the treating physician) to interfere with the safety or efficacy assessment of the investigational regimen

• Patients must not be pregnant due to the potential teratogenic side effects of the protocol treatment. Women of reproductive potential and men must have agreed to use an effective contraception method for the duration of protocol treatment, and for 5 months (150 days) after the last dose of atezolizumab. A woman is considered to be of reproductive potential if she has had a menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, effective contraception also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, breastfeeding must be discontinued prior to randomization

• Patients of reproductive potential must have a negative serum pregnancy test within 14 days prior to randomization

• Patients must not have known active tuberculosis

• Patients must not have received a live, attenuated vaccine within 28 days prior to randomization

‣ NOTE: All coronavirus disease 2019 (COVID-19) vaccines that have received Food and Drug Administration (FDA) approval or FDA emergency use authorization are acceptable

• Patients must not have a known history of allergic reactions attributed to compounds of similar chemical or biologic composition to atezolizumab

• Patients must not have a known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric antibodies, fusion proteins, or Chinese hamster ovary cell products or to any component of the atezolizumab formulation

• Patient must agree to have specimens submitted for translational medicine and banking

• Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

• As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

• Patients who can complete quality of life instruments in English, French, or Spanish must agree to complete the questionnaires at the protocol-specified time points

Locations
United States
Alaska
Providence Alaska Medical Center
Anchorage
Arkansas
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro
University of Arkansas for Medical Sciences
Little Rock
California
Kaiser Permanente-Deer Valley Medical Center
Antioch
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield
Alta Bates Summit Medical Center-Herrick Campus
Berkeley
Tower Cancer Research Foundation
Beverly Hills
Kaiser Permanente Dublin
Dublin
Kaiser Permanente-Fremont
Fremont
Kaiser Permanente-Fresno
Fresno
Loma Linda University Medical Center
Loma Linda
Veterans Affairs Loma Linda Healthcare System
Loma Linda
Tibor Rubin VA Medical Center
Long Beach
Cedars Sinai Medical Center
Los Angeles
Los Angeles General Medical Center
Los Angeles
USC / Norris Comprehensive Cancer Center
Los Angeles
Fremont - Rideout Cancer Center
Marysville
Kaiser Permanente-Modesto
Modesto
Memorial Medical Center
Modesto
Kaiser Permanente-Oakland
Oakland
Saint Joseph Hospital - Orange
Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange
Desert Regional Medical Center
Palm Springs
Kaiser Permanente-Richmond
Richmond
Kaiser Permanente-Roseville
Roseville
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville
Sutter Roseville Medical Center
Roseville
The Permanente Medical Group-Roseville Radiation Oncology
Roseville
Kaiser Permanente Downtown Commons
Sacramento
Kaiser Permanente-South Sacramento
Sacramento
Sutter Medical Center Sacramento
Sacramento
University of California Davis Comprehensive Cancer Center
Sacramento
California Pacific Medical Center-Pacific Campus
San Francisco
Kaiser Permanente-San Francisco
San Francisco
Veterans Affairs Medical Center - San Francisco
San Francisco
Kaiser Permanente-Santa Teresa-San Jose
San Jose
Kaiser Permanente San Leandro
San Leandro
Kaiser San Rafael-Gallinas
San Rafael
Kaiser Permanente Medical Center - Santa Clara
Santa Clara
Kaiser Permanente-Santa Rosa
Santa Rosa
Kaiser Permanente Cancer Treatment Center
South San Francisco
Kaiser Permanente-South San Francisco
South San Francisco
Kaiser Permanente-Stockton
Stockton
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee
Kaiser Permanente Medical Center-Vacaville
Vacaville
Kaiser Permanente-Vallejo
Vallejo
Sutter Solano Medical Center/Cancer Center
Vallejo
Kaiser Permanente-Walnut Creek
Walnut Creek
Presbyterian Intercommunity Hospital
Whittier
Colorado
Rocky Mountain Regional VA Medical Center
Aurora
UCHealth University of Colorado Hospital
Aurora
Memorial Hospital North
Colorado Springs
Penrose-Saint Francis Healthcare
Colorado Springs
UCHealth Memorial Hospital Central
Colorado Springs
Kaiser Permanente-Franklin
Denver
Cancer Care and Hematology-Fort Collins
Fort Collins
Poudre Valley Hospital
Fort Collins
Banner North Colorado Medical Center
Greeley
UCHealth Greeley Hospital
Greeley
UCHealth Highlands Ranch Hospital
Highlands Ranch
Kaiser Permanente-Rock Creek
Lafayette
Kaiser Permanente-Lone Tree
Lone Tree
Banner North Colorado Medical Center - Loveland Campus
Loveland
Medical Center of the Rockies
Loveland
Connecticut
Smilow Cancer Hospital Care Center-Fairfield
Fairfield
Smilow Cancer Hospital Care Center at Greenwich
Greenwich
Smilow Cancer Hospital Care Center - Guilford
Guilford
Smilow Cancer Hospital-Hamden Care Center
Hamden
Yale University
New Haven
Yale-New Haven Hospital North Haven Medical Center
North Haven
Smilow Cancer Hospital Care Center-Trumbull
Trumbull
Smilow Cancer Hospital Care Center - Waterford
Waterford
Washington, D.c.
George Washington University Medical Center
Washington D.c.
Delaware
Bayhealth Hospital Kent Campus
Dover
Beebe South Coastal Health Campus
Millville
Helen F Graham Cancer Center
Newark
Medical Oncology Hematology Consultants PA
Newark
Beebe Health Campus
Rehoboth Beach
Florida
GenesisCare USA - Aventura
Aventura
GenesisCare USA - Aventura FP
Aventura
Jupiter Medical Center
Jupiter
Orlando Health Cancer Institute
Orlando
Memorial Hospital West
Pembroke Pines
GenesisCare USA - Plantation
Plantation
Florida Cancer Specialists - Sarasota
Sarasota
Florida Cancer Specialists - Sarasota Downtown
Sarasota
Sarasota Memorial Health Care Center at University Parkway
Sarasota
Sarasota Memorial Hospital
Sarasota
Georgia
Augusta Oncology Associates PC-D'Antignac
Augusta
Augusta University Medical Center
Augusta
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah
Memorial Health University Medical Center
Savannah
Hawaii
Hawaii Cancer Care - Westridge
‘aiea
Pali Momi Medical Center
‘aiea
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu
Queen's Cancer Cenrer - POB I
Honolulu
Queen's Cancer Center - Kuakini
Honolulu
Queen's Medical Center
Honolulu
Straub Clinic and Hospital
Honolulu
The Cancer Center of Hawaii-Liliha
Honolulu
Iowa
McFarland Clinic - Ames
Ames
Mercy Cancer Center-West Lakes
Clive
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive
Greater Regional Medical Center
Creston
Mercy Medical Center - Des Moines
Des Moines
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines
Mercy Medical Center-West Lakes
West Des Moines
Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell
Saint Alphonsus Cancer Care Center-Nampa
Nampa
Illinois
Rush-Copley Medical Center
Aurora
Illinois CancerCare-Bloomington
Bloomington
OSF Saint Joseph Medical Center
Bloomington
Illinois CancerCare-Canton
Canton
Illinois CancerCare-Carthage
Carthage
Jesse Brown Veterans Affairs Medical Center
Chicago
University of Illinois
Chicago
Decatur Memorial Hospital
Decatur
Crossroads Cancer Center
Effingham
Illinois CancerCare-Eureka
Eureka
Illinois CancerCare-Galesburg
Galesburg
Western Illinois Cancer Treatment Center
Galesburg
Illinois CancerCare-Kewanee Clinic
Kewanee
Illinois CancerCare-Macomb
Macomb
Loyola University Medical Center
Maywood
Illinois CancerCare-Ottawa Clinic
Ottawa
Illinois CancerCare-Pekin
Pekin
Illinois CancerCare-Peoria
Peoria
Methodist Medical Center of Illinois
Peoria
OSF Saint Francis Medical Center
Peoria
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria
Illinois CancerCare-Peru
Peru
Illinois CancerCare-Princeton
Princeton
UW Health Carbone Cancer Center Rockford
Rockford
Southern Illinois University School of Medicine
Springfield
Springfield Clinic
Springfield
Springfield Memorial Hospital
Springfield
Carle Cancer Center
Urbana
Indiana
Community Cancer Center South
Indianapolis
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis
Kansas
Ascension Via Christi Hospitals Wichita
Wichita
Kentucky
Saint Joseph Hospital East
Lexington
Louisiana
Louisiana Hematology Oncology Associates LLC
Baton Rouge
LSU Health Baton Rouge-North Clinic
Baton Rouge
Mary Bird Perkins Cancer Center
Baton Rouge
Our Lady of the Lake Physician Group
Baton Rouge
Mary Bird Perkins Cancer Center - Houma
Houma
Terrebonne General Medical Center
Houma
East Jefferson General Hospital
Metairie
Massachusetts
Beverly Hospital
Beverly
Lahey Hospital and Medical Center
Burlington
Addison Gilbert Hospital
Gloucester
Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care
Winchester
Maryland
UM Saint Joseph Medical Center
Towson
Michigan
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor
Trinity Health Medical Center - Brighton
Brighton
Trinity Health Medical Center - Canton
Canton
Chelsea Hospital
Chelsea
Michigan Healthcare Professionals Clarkston
Clarkston
Corewell Health Dearborn Hospital
Dearborn
Henry Ford Health Saint John Hospital
Detroit
Henry Ford Hospital
Detroit
Corewell Health Farmington Hills Hospital
Farmington Hills
Michigan Healthcare Professionals Farmington
Farmington Hills
Genesys Hurley Cancer Institute
Flint
West Michigan Cancer Center
Kalamazoo
University of Michigan Health - Sparrow Lansing
Lansing
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia
Michigan Healthcare Professionals Macomb
Macomb
Corewell Health Lakeland Hospitals - Niles Hospital
Niles
Henry Ford Health Providence Novi Hospital
Novi
Michigan Healthcare Professionals Pontiac
Pontiac
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac
Corewell Health William Beaumont University Hospital
Royal Oak
MyMichigan Medical Center Saginaw
Saginaw
Oncology Hematology Associates of Saginaw Valley PC
Saginaw
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph
Henry Ford Health Providence Southfield Hospital
Southfield
MyMichigan Medical Center Tawas
Tawas City
Munson Medical Center
Traverse City
Corewell Health Beaumont Troy Hospital
Troy
Michigan Healthcare Professionals Troy
Troy
Henry Ford Health Warren Hospital
Warren
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch
University of Michigan Health - West
Wyoming
Minnesota
Sanford Joe Lueken Cancer Center
Bemidji
Miller-Dwan Hospital
Duluth
Abbott-Northwestern Hospital
Minneapolis
Hennepin County Medical Center
Minneapolis
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park
Regions Hospital
Saint Paul
Missouri
Saint Francis Medical Center
Cape Girardeau
Parkland Health Center - Farmington
Farmington
Freeman Health System
Joplin
Kansas City Veterans Affairs Medical Center
Kansas City
Phelps Health Delbert Day Cancer Institute
Rolla
Heartland Regional Medical Center
Saint Joseph
Sainte Genevieve County Memorial Hospital
Sainte Genevieve
CoxHealth South Hospital
Springfield
Mercy Hospital Springfield
Springfield
Missouri Baptist Medical Center
St Louis
Missouri Baptist Sullivan Hospital
Sullivan
BJC Outpatient Center at Sunset Hills
Sunset Hills
Mississippi
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus
Baptist Cancer Center-Grenada
Grenada
University of Mississippi Medical Center
Jackson
Baptist Memorial Hospital and Cancer Center-Union County
New Albany
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven
Montana
Billings Clinic Cancer Center
Billings
Bozeman Health Deaconess Hospital
Bozeman
Saint James Community Hospital and Cancer Treatment Center
Butte
Benefis Sletten Cancer Institute
Great Falls
North Carolina
Messino Cancer Centers
Asheville
Rex Hematology Oncology Associates-Cary
Cary
Novant Health Presbyterian Medical Center
Charlotte
Durham VA Medical Center
Durham
Rex Hematology Oncology Associates-Garner
Garner
CaroMont Regional Medical Center
Gastonia
Margaret R Pardee Memorial Hospital
Hendersonville
Novant Health Cancer Institute - Huntersville
Huntersville
Novant Health Cancer Institute - Kernersville
Kernersville
Novant Health Cancer Institute - Matthews
Matthews
CarolinaEast Medical Center
New Bern
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst
UNC Rex Cancer Center of Wakefield
Raleigh
UNC Rex Healthcare
Raleigh
Novant Cancer Institute Radiation Oncology - Supply
Supply
Novant Health Cancer Institute Radiation Oncology - Wilmington
Wilmington
Novant Health New Hanover Regional Medical Center
Wilmington
Novant Health Forsyth Medical Center
Winston-salem
North Dakota
Sanford Bismarck Medical Center
Bismarck
Sanford Broadway Medical Center
Fargo
Sanford Roger Maris Cancer Center
Fargo
Nebraska
Nebraska Medicine-Bellevue
Bellevue
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island
CHI Health Good Samaritan
Kearney
Nebraska Medicine-Village Pointe
Omaha
University of Nebraska Medical Center
Omaha
New Jersey
Memorial Sloan Kettering Basking Ridge
Basking Ridge
Cooper Hospital University Medical Center
Camden
Memorial Sloan Kettering Monmouth
Middletown
Memorial Sloan Kettering Bergen
Montvale
Capital Health Medical Center-Hopewell
Pennington
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees Township
New Mexico
University of New Mexico Cancer Center
Albuquerque
New York
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn
Roswell Park Cancer Institute
Buffalo
Memorial Sloan Kettering Commack
Commack
Mary Imogene Bassett Hospital
Cooperstown
The Cancer Institute at Saint Francis Hospital
East Hills
Arnot Ogden Medical Center/Falck Cancer Center
Elmira
Memorial Sloan Kettering Westchester
Harrison
Northwell Health/Center for Advanced Medicine
Lake Success
Lenox Hill Hospital
New York
Manhattan Eye Ear and Throat Hospital
New York
Memorial Sloan Kettering Cancer Center
New York
Mount Sinai Chelsea
New York
Mount Sinai Hospital
New York
Mount Sinai West
New York
State University of New York Upstate Medical University
Syracuse
Montefiore Medical Center - Moses Campus
The Bronx
Montefiore Medical Center-Einstein Campus
The Bronx
Memorial Sloan Kettering Nassau
Uniondale
Good Samaritan University Hospital
West Islip
Ohio
Miami Valley Hospital South
Centerville
Adena Regional Medical Center
Chillicothe
Good Samaritan Hospital - Cincinnati
Cincinnati
MetroHealth Medical Center
Cleveland
Ohio State University Comprehensive Cancer Center
Columbus
The Mark H Zangmeister Center
Columbus
Miami Valley Hospital
Dayton
Miami Valley Hospital North
Dayton
Premier Blood and Cancer Center
Dayton
Atrium Medical Center-Middletown Regional Hospital
Franklin
Mount Carmel Grove City Hospital
Grove City
Upper Valley Medical Center
Troy
Saint Ann's Hospital
Westerville
Genesis Healthcare System Cancer Care Center
Zanesville
Oklahoma
Cancer Centers of Southwest Oklahoma Research
Lawton
Mercy Hospital Oklahoma City
Oklahoma City
University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
Clackamas Radiation Oncology Center
Clackamas
Legacy Mount Hood Medical Center
Gresham
Legacy Good Samaritan Hospital and Medical Center
Portland
Providence Portland Medical Center
Portland
Providence Saint Vincent Medical Center
Portland
Legacy Meridian Park Hospital
Tualatin
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Allentown
Geisinger Medical Center
Danville
Delaware County Memorial Hospital
Drexel Hill
Pocono Medical Center
East Stroudsburg
Penn State Milton S Hershey Medical Center
Hershey
IRMC Cancer Center
Indiana
Geisinger Medical Oncology-Lewisburg
Lewisburg
UPMC Cancer Center - Monroeville
Monroeville
Jefferson Torresdale Hospital
Philadelphia
Thomas Jefferson University Hospital
Philadelphia
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh
UPMC-Saint Margaret
Pittsburgh
UPMC-Shadyside Hospital
Pittsburgh
Geisinger Cancer Services-Pottsville
Pottsville
Geisinger Medical Oncology-Selinsgrove
Selinsgrove
Reading Hospital
West Reading
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-barre
Asplundh Cancer Pavilion
Willow Grove
Rhode Island
Rhode Island Hospital
Providence
South Carolina
Saint Joseph's/Candler - Bluffton Campus
Bluffton
McLeod Regional Medical Center
Florence
Gibbs Cancer Center-Gaffney
Gaffney
Saint Francis Cancer Center
Greenville
Saint Francis Hospital
Greenville
Gibbs Cancer Center-Pelham
Greer
Spartanburg Medical Center
Spartanburg
South Dakota
Sanford Cancer Center Oncology Clinic
Sioux Falls
Sanford USD Medical Center - Sioux Falls
Sioux Falls
Tennessee
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville
Ballad Health Cancer Care - Kingsport
Kingsport
Wellmont Holston Valley Hospital and Medical Center
Kingsport
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis
Texas
MD Anderson in The Woodlands
Conroe
M D Anderson Cancer Center
Houston
MD Anderson West Houston
Houston
MD Anderson League City
League City
MD Anderson in Sugar Land
Sugar Land
Utah
George E Wahlen Department of Veterans Affairs Medical Center
Salt Lake City
Huntsman Cancer Institute/University of Utah
Salt Lake City
Virginia
Inova Schar Cancer Institute
Fairfax
Augusta Health Center for Cancer and Blood Disorders
Fishersville
Ballad Health Cancer Care - Norton
Norton
Washington
Virginia Mason Medical Center
Seattle
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver
Legacy Salmon Creek Hospital
Vancouver
Wisconsin
Langlade Hospital and Cancer Center
Antigo
Ascension Saint Elizabeth Hospital
Appleton
ThedaCare Regional Cancer Center
Appleton
Northwest Wisconsin Cancer Center
Ashland
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield
Aurora Cancer Care-Southern Lakes VLCC
Burlington
Ascension Calumet Hospital
Chilton
HSHS Sacred Heart Hospital
Eau Claire
Marshfield Medical Center-EC Cancer Center
Eau Claire
Ascension Saint Francis - Reiman Cancer Center
Franklin
Aurora Health Care Germantown Health Center
Germantown
Aurora Cancer Care-Grafton
Grafton
Aurora BayCare Medical Center
Green Bay
Bellin Memorial Hospital
Green Bay
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Green Bay
Aurora Cancer Care-Kenosha South
Kenosha
Gundersen Lutheran Medical Center
La Crosse
Mayo Clinic Health System-Franciscan Healthcare
La Crosse
University of Wisconsin Carbone Cancer Center - University Hospital
Madison
William S Middleton VA Medical Center
Madison
Aurora Bay Area Medical Group-Marinette
Marinette
Marshfield Medical Center-Marshfield
Marshfield
Aspirus Medford Hospital
Medford
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee
Aurora Cancer Care-Milwaukee
Milwaukee
Aurora Saint Luke's Medical Center
Milwaukee
Aurora Sinai Medical Center
Milwaukee
Marshfield Medical Center - Minocqua
Minocqua
ProHealth D N Greenwald Center
Mukwonago
ThedaCare Cancer Care - New London
New London
ProHealth Oconomowoc Memorial Hospital
Oconomowoc
Ascension Mercy Hospital
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh
Ascension All Saints Hospital
Racine
Aurora Cancer Care-Racine
Racine
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander
Marshfield Medical Center-Rice Lake
Rice Lake
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan
Aspirus Cancer Care - Stevens Point
Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Stevens Point
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay
Aurora Medical Center in Summit
Summit
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers
UW Cancer Center at ProHealth Care
Waukesha
Aspirus Regional Cancer Center
Wausau
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa
Aurora Cancer Care-Milwaukee West
Wauwatosa
Aurora West Allis Medical Center
West Allis
Marshfield Medical Center - Weston
Weston
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids
West Virginia
West Virginia University Charleston Division
Charleston
Edwards Comprehensive Cancer Center
Huntington
Wheeling Hospital/Schiffler Cancer Center
Wheeling
Time Frame
Start Date: 2020-08-13
Completion Date: 2028-05-01
Participants
Target number of participants: 480
Treatments
Experimental: Arm A (atezolizumab, SBRT)
Patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 1 cycle 3, patients also undergo SBRT for 3-8 treatments every 2 days or QD over 1-3 weeks. Patients undergo FDG-PET/CT during screening. Patients undergo blood sample collection and CT scans throughout the trial.
Active_comparator: Arm B (SBRT)
Beginning 21 days after randomization, patients undergo SBRT for 3-8 treatments every 2 days or QD over 1-3 weeks. Patients undergo FDG-PET/CT during screening. Patients undergo blood sample collection and CT scans throughout the trial.
Authors
Michael J. Kelley, Kathleen J. Yost, Shiven Patel, Deepti Behl, Jeffrey A. Kittel, Stephen K. Ronson, Charles S. Kuzma, Paul J. Hesketh, Hassan I. Tahsildar, Pairote Jaroonwanichkul, Philip J. Stella, Bryan A. Faller, Meng X. Welliver, Preston D. Steen, Nadia K. Malik, Matthew M. Harkenrider, Shirnett K. Williamson, Asheesh Shipstone, Timothy V. Waxweiler, Jay W. Carlson, Charles W. Drescher, Jeffrey L. Berenberg, Jason C. Ye, Maria Werner-Wasik, Lawrence E. Feldman, Jonathan Ticku, Timothy R. Wassenaar, Howard A. Zaren, John M. Schallenkamp, Tareq Al Baghdadi, Frank A. Vicini, Christopher H. Chay, Jennifer Vogel, Megan E. Daly, Supriya Jain, Andrew M. Baschnagel, Weining Zhen, Iftekhar A. Khan, Dennis P. Morgan, Alexander Menter, Albert Attia, Michael D. Mix, Mark E. Reeves, Hamid R. Mirshahidi, Lynn J. Howie, Nicholas DiBella, Fiori Alite, Faisal Musa, Michael L. Haas, Debra M. Prow, Robert M. Kyler, Serge Dauphin, Jacqueline Vuky, Rajesh Bajaj, Sanjay Maraboyina, Chad G. Rusthoven, Jeremy M. Kilburn, Adam M. Forman, David S. Hanson, Garrett B. Sherwood, Praveen Vashist, Charles B. Simone, Kelvin B. Raybon, Michael A. Papagikos, Robert M. Samstein, Jondavid Pollock, Richard F. Gorman, Kristine E. Kokeny, Harvey E. Einhorn, Bret E. Friday, Onyekachi H. Ogbonna, William A. Conkright, Pankaj Gupta, Richard L. Deming, David F. Lee, Scott H. Okuno, David M. King, Marwan Massouh, Henry S. Park, Raid Aljumaily, Jessica D. McDermott, Michael D. Hasselle, Philip E. Lammers, Glen P. Morehead, Atul Kumar, David E. Marinier, Rachelle M. Lanciano, Gregory A. Masters
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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